SPOON FORCEPS, 11MM— 510(k) K911364

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K911364 for SPOON FORCEPS, 11MM, Substantially Equivalent on 1991-10-23. Applicant: Northgate Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Northgate Technologies, Inc.
Product code
Code LQC
Device class
Class 2
Regulation
21 CFR 876.4500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arlington Heights, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LQC

product code LQC
Death
7
Injury
247
Malfunction
956
Total
1,210

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.